The Asian Transcatheter Aortic Valve Replacement Registry (Asian TAVR)

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Diseases
• Intervention / Treatment: Device: transcatheter aortic valve replacement

Detailed Description

This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

• Study Type: Observational
• Enrollment (Actual): 1505

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Elizabeth Hospital
• Japan
  • Kamakura, Japan
    • Shonan Kamakura General Hospital
  • Kitakyushu, Japan
    • Kokura Memorial Hospital
  • Minato, Japan
    • Keio University
  • Tokyo, Japan
    • Teikyo University School of Medicine
  • Yokohama, Japan
    • Saiseikai Yokohama-City Eastern Hospital
• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Sejong Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center
• Singapore
  • Singapore, Singapore
    • National University Heart Centre
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who will undergo TAVR in Asian Pacific countries

Description

Inclusion Criteria:

• Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death	3 years
Death	1 year
Death	5 years
Death	1 month
Death	6 months
Death	2 years
Death	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarction	6 months
Myocardial infarction	3 years
Myocardial infarction	1 year
Stroke	5 years
Myocardial infarction	5 years
Stroke	4 years
Stroke	1 year
Death from cardiac cause	1 month
Death from cardiac cause	6 months
Death from cardiac cause	1 year
Death from cardiac cause	2 years
Death from cardiac cause	3 years
Death from cardiac cause	4 years
Death from cardiac cause	5 years
Stroke	1 month
Stroke	6 months
Stroke	2 years
Stroke	3 years
Myocardial infarction	1 month
Myocardial infarction	2 years
Myocardial infarction	4 years
Repeat hospitalization	1 month
Repeat hospitalization	6 months
Repeat hospitalization	1 year
Repeat hospitalization	2 years
Repeat hospitalization	3 years
Repeat hospitalization	4 years
Repeat hospitalization	5 years
Acute kidney injury	1 month
Acute kidney injury	6 months
Acute kidney injury	1 year
Acute kidney injury	2 years
Acute kidney injury	3 years
Acute kidney injury	4 years
Acute kidney injury	5 years
Vascular complication	1 month
Vascular complication	6 months
Vascular complication	1 year
Vascular complication	2 years
Vascular complication	3 years
Vascular complication	4 years
Vascular complication	5 years
Bleeding events	1 month
Bleeding events	6 months
Bleeding events	1 year
Bleeding events	2 years
Bleeding events	3 years
Bleeding events	4 years
Bleeding events	5 years
Device success	1 month
Device success	6 months
Device success	1 year
Device success	2 years
Device success	3 years
Device success	4 years
Device success	5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Seung-jung Park, MD, Asan Medical Center; Principal Investigator: Paul Hsien Li Kao, MD, National Taiwan University, Taiwan; Principal Investigator: Gerald Yong, MD, Royal Perth Hospital, Australia; Principal Investigator: Kentaro Hayashida, MD, Keio University, JAPAN

Publications and helpful links

General Publications

• Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: asian; transcatheter aortic valve replacement; asian pacific
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Diseases
• Other Study ID Numbers: AMCCV2014-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.